INTRODUCTION
The use of well-characterized materials to construct packaging systems is a primary means of ensuring that the packaging system is suited for its intended use. Materials are characterized so that their properties and characteristics can be matched to the performance requirements of the packaging system, thus facilitating the intentional selection of appropriate materials. For the purposes of this chapter, a plastic material of construction is considered to be well characterized for its intended use if the following characteristics have been adequately established: its identity, biocompatibility (biological reactivity), general physicochemical properties, and composition (i.e., additives likely to be present). ▲Extractable elements may also be relevant to the selection of a packaging system’s materials of construction and therefore a relevant aspect of material characterization. Materials of construction can vary widely in terms of their intentionally and unintentionally added elements and their potential use. Because of this, it is challenging to provide universally effective and efficient tests methodologies, lists of target elements and reporting requirements. It is the material user’s responsibility to evaluate the need for extractable elements testing and, if such testing is necessary, to establish and justify the means by which testing is accomplished, taking into account extraction conditions, target elements, and reporting requirement. An example of an extractable elements testing strategy is provided in Evaluation of Plastic Packaging Systems and Their Materials of Construction with Respect to Their User Safety Impact 〈1661〉.▲ (USP 1-Aug-2020)
Source from USP and Please refer to USP for details:
plastic pharmaceutical packaging
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